FilmArray® Pneumonia Panel plus (Pneumoplus)

GUDID 00815381020314

IVD reagent kit containing 30 tests

BIOFIRE DIAGNOSTICS, LLC

Multiple respiratory pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00815381020314
NIH Device Record Key5beb6ea9-fb0c-46a4-87b9-859faf61fc2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameFilmArray® Pneumonia Panel plus (Pneumoplus)
Version Model NumberRFIT-ASY-0143
Company DUNS079280262
Company NameBIOFIRE DIAGNOSTICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100815381020314 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QDSMers-Cov And Common Respiratory Pathogens Semi-Quantitative And Quantitative Multiplex Nucleic Acid Detection System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-01-14
Device Publish Date2018-12-12

On-Brand Devices [FilmArray® Pneumonia Panel plus (Pneumoplus)]

00815381020321IVD reagent kit containing 6 tests
00815381020314IVD reagent kit containing 30 tests

Trademark Results [FilmArray]

Mark Image

Registration | Serial
Company
Trademark
Application Date
FILMARRAY
FILMARRAY
85939258 4554601 Live/Registered
BioFire Diagnostics, Inc.
2013-05-22
FILMARRAY
FILMARRAY
77083897 3761522 Live/Registered
BIOFIRE DIAGNOSTICS, LLC
2007-01-16

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